Amlodipine and Benazapril HCL Capsules, USP, 5 mg/10 mg, 100 count bottles, Mylan Pharmaceuticals, Inc., Morgantown, WV --- NDC 0378-6896-01
Reported: May 23, 2018 Initiated: April 24, 2018 #D-0819-2018
Product Description
Amlodipine and Benazapril HCL Capsules, USP, 5 mg/10 mg, 100 count bottles, Mylan Pharmaceuticals, Inc., Morgantown, WV --- NDC 0378-6896-01
Reason for Recall
cGMP Deviations; cleaning process for equipment used to manufacture the specified batches was not followed according to procedure
Details
- Recalling Firm
- Mylan Pharmaceuticals Inc.
- Units Affected
- 25,488 bottles
- Distribution
- Product was distributed throughout United States
- Location
- Morgantown, WV
Frequently Asked Questions
What product was recalled? ▼
Amlodipine and Benazapril HCL Capsules, USP, 5 mg/10 mg, 100 count bottles, Mylan Pharmaceuticals, Inc., Morgantown, WV --- NDC 0378-6896-01. Recalled by Mylan Pharmaceuticals Inc.. Units affected: 25,488 bottles.
Why was this product recalled? ▼
cGMP Deviations; cleaning process for equipment used to manufacture the specified batches was not followed according to procedure
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on May 23, 2018. Severity: Moderate. Recall number: D-0819-2018.
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